HRP20160223T1 - POSTUPAK ZA PRIPREMANJE PRIPRAVAKA OKSIKODON HIDROKLORIDA KOJI IMAJU MANJE OD 25ppm 14-HIDROKSIKODEINONA - Google Patents
POSTUPAK ZA PRIPREMANJE PRIPRAVAKA OKSIKODON HIDROKLORIDA KOJI IMAJU MANJE OD 25ppm 14-HIDROKSIKODEINONA Download PDFInfo
- Publication number
- HRP20160223T1 HRP20160223T1 HRP20160223T HRP20160223T HRP20160223T1 HR P20160223 T1 HRP20160223 T1 HR P20160223T1 HR P20160223 T HRP20160223 T HR P20160223T HR P20160223 T HRP20160223 T HR P20160223T HR P20160223 T1 HRP20160223 T1 HR P20160223T1
- Authority
- HR
- Croatia
- Prior art keywords
- solvent
- hydroxycodeinone
- dihydrocodeinone
- dihydroxy
- mentioned solvents
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 5
- YYCRAERBSFHMPL-XFKAJCMBSA-N (4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,7a,13-tetrahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one Chemical compound O=C([C@@H]1O2)C=C[C@@]3(O)[C@]4([H])N(C)CC[C@]13C1=C2C(OC)=CC=C1C4 YYCRAERBSFHMPL-XFKAJCMBSA-N 0.000 title claims 4
- YYCRAERBSFHMPL-UHFFFAOYSA-N 14beta-Hydroxycodeinone Natural products O1C2C(=O)C=CC3(O)C4CC5=CC=C(OC)C1=C5C23CCN4C YYCRAERBSFHMPL-UHFFFAOYSA-N 0.000 title claims 4
- BQNSLJQRJAJITR-UHFFFAOYSA-N 1,1,2-trichloro-1,2-difluoroethane Chemical compound FC(Cl)C(F)(Cl)Cl BQNSLJQRJAJITR-UHFFFAOYSA-N 0.000 title claims 2
- 229960003617 oxycodone hydrochloride Drugs 0.000 title claims 2
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000002904 solvent Substances 0.000 claims 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 8
- 238000000034 method Methods 0.000 claims 7
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims 6
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 5
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims 4
- 229960000240 hydrocodone Drugs 0.000 claims 4
- SECXISVLQFMRJM-UHFFFAOYSA-N N-Methylpyrrolidone Chemical compound CN1CCCC1=O SECXISVLQFMRJM-UHFFFAOYSA-N 0.000 claims 3
- BRUQQQPBMZOVGD-XFKAJCMBSA-N Oxycodone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C BRUQQQPBMZOVGD-XFKAJCMBSA-N 0.000 claims 3
- 229960002085 oxycodone Drugs 0.000 claims 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 claims 2
- RYHBNJHYFVUHQT-UHFFFAOYSA-N 1,4-Dioxane Chemical compound C1COCCO1 RYHBNJHYFVUHQT-UHFFFAOYSA-N 0.000 claims 1
- 150000001408 amides Chemical class 0.000 claims 1
- 150000001732 carboxylic acid derivatives Chemical class 0.000 claims 1
- 239000003054 catalyst Substances 0.000 claims 1
- 238000004128 high performance liquid chromatography Methods 0.000 claims 1
- 239000000852 hydrogen donor Substances 0.000 claims 1
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 claims 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D489/00—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula:
- C07D489/06—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula: with a hetero atom directly attached in position 14
- C07D489/08—Oxygen atom
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D489/00—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula:
- C07D489/02—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula: with oxygen atoms attached in positions 3 and 6, e.g. morphine, morphinone
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D489/00—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula:
- C07D489/02—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula: with oxygen atoms attached in positions 3 and 6, e.g. morphine, morphinone
- C07D489/04—Salts; Organic complexes
Claims (6)
1. Postupak za pripremanje pripravka oksikodon hidroklorida koji ima razinu 14-hidroksikodeinona u količini manjoj od 25 ppm kako je određeno s HPLC postupkom prema primjeru 6, koji sadrži
reakciju u pogodnom otapalu pripravka baze oksikodona koji ima količinu 8,14-dihidroksi-7,8-dihidrokodeinona s klorovodičnom kiselinom u količini većoj od 1.0 molarnih ekvivalenata u usporedbi sa pripravkom baze oksikodona, pri čemu je 8,14-dihidroksi-7,8-dihidrokodeinon dehidriran u 14-hidroksikodeinon, i pod redukcijskim uvjetima koji su osigurani s katalizatorom i donorom vodika, pri čemu se 14-hidroksikodeinon pretvara u oksikodon, naznačen time da je otapalo izabrano iz skupine koja sadrži vodu, alkohol, eter, amid, N-metilpirolidon, karboksilnu kiselinu, te odgovarajuću smjesu bilo koja dva ili više od navedenih otapala.
2. Postupak prema zahtjevu 1, naznačen time da je otapalo izabrano iz skupine koja sadrži vodu, alkohol, eter, N-metilpirolidon, te odgovarajuću smjesu bilo koja dva ili više od navedenih otapala.
3. Postupak prema zahtjevu 2, naznačen time da je otapalo izabrano iz skupine koja sadrži vodu, izopropanol, metanol, etanol, tetrahidrofuran, dioksan, N-metilpirolidon, te odgovarajuću smjesu bilo koja dva ili više od navedenih otapala.
4. Postupak prema zahtjevu 3, naznačen time da je otapalo izabrano iz skupine koja sadrži vodu, izopropanol, metanol, etanol, te odgovarajuću smjesu bilo koja dva ili više od navedenih otapala.
5. Postupak prema zahtjevu 4, naznačen time da je otapalo kombinacija izopropanola i vode.
6. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time da 8,14-dihidroksi-7,8-dihidrokodeinon je 8a,14-dihidroksi-7,8-dihidrokodeinon.
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US55749204P | 2004-03-30 | 2004-03-30 | |
US60153404P | 2004-08-13 | 2004-08-13 | |
US62007204P | 2004-10-18 | 2004-10-18 | |
US64862505P | 2005-01-31 | 2005-01-31 | |
US65177805P | 2005-02-10 | 2005-02-10 | |
EP11186168.8A EP2426132B1 (en) | 2004-03-30 | 2005-03-30 | Process for preparing oxycodone hydrochloride compositions having less than 25ppm 14-hydroxycodeinone |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20160223T1 true HRP20160223T1 (hr) | 2016-03-25 |
Family
ID=35124996
Family Applications (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20110425TT HRP20110425T4 (hr) | 2004-03-30 | 2011-06-07 | Postupak za pripremu oksikodon hidroklorida koji ima manje od 25 ppm 14-hidroksikodeinona |
HRP20150358TT HRP20150358T1 (hr) | 2004-03-30 | 2015-03-30 | Farmaceutski oblik doziranja koji sadrži oksikodon hidroklorid koji ima manje od 25 ppm 14-hidroksikodeinona |
HRP20160223T HRP20160223T1 (hr) | 2004-03-30 | 2016-03-01 | POSTUPAK ZA PRIPREMANJE PRIPRAVAKA OKSIKODON HIDROKLORIDA KOJI IMAJU MANJE OD 25ppm 14-HIDROKSIKODEINONA |
HRP20160885TT HRP20160885T1 (hr) | 2004-03-30 | 2016-07-15 | Postupak za pripremu oksikodon hidroklorida koji sadrži manje od 25ppm 14-hidroksikodeinona |
HRP20180407TT HRP20180407T1 (hr) | 2004-03-30 | 2018-03-08 | Postupak za pripremu oksikodon hidroklorida koji ima manje od 25 ppm 14- hidroksikodeinona |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20110425TT HRP20110425T4 (hr) | 2004-03-30 | 2011-06-07 | Postupak za pripremu oksikodon hidroklorida koji ima manje od 25 ppm 14-hidroksikodeinona |
HRP20150358TT HRP20150358T1 (hr) | 2004-03-30 | 2015-03-30 | Farmaceutski oblik doziranja koji sadrži oksikodon hidroklorid koji ima manje od 25 ppm 14-hidroksikodeinona |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20160885TT HRP20160885T1 (hr) | 2004-03-30 | 2016-07-15 | Postupak za pripremu oksikodon hidroklorida koji sadrži manje od 25ppm 14-hidroksikodeinona |
HRP20180407TT HRP20180407T1 (hr) | 2004-03-30 | 2018-03-08 | Postupak za pripremu oksikodon hidroklorida koji ima manje od 25 ppm 14- hidroksikodeinona |
Country Status (39)
Country | Link |
---|---|
US (35) | US7129248B2 (hr) |
EP (7) | EP2314589B1 (hr) |
JP (8) | JP4912294B2 (hr) |
KR (12) | KR20100069719A (hr) |
CN (5) | CN101812065B (hr) |
AP (1) | AP2232A (hr) |
AR (1) | AR049012A1 (hr) |
AT (2) | ATE501150T1 (hr) |
AU (2) | AU2005230826C1 (hr) |
BR (1) | BRPI0508758B8 (hr) |
CA (3) | CA2557845C (hr) |
CR (2) | CR8593A (hr) |
CY (5) | CY1111487T1 (hr) |
DE (2) | DE202005021371U1 (hr) |
DK (6) | DK1730151T4 (hr) |
EA (1) | EA013208B1 (hr) |
EC (1) | ECSP066953A (hr) |
ES (6) | ES2665287T3 (hr) |
FI (1) | FI7843U1 (hr) |
HK (3) | HK1098745A1 (hr) |
HR (5) | HRP20110425T4 (hr) |
HU (3) | HUE036451T2 (hr) |
IL (8) | IL178038A (hr) |
LT (2) | LT2316837T (hr) |
MA (1) | MA28492B1 (hr) |
ME (4) | ME02411B (hr) |
MX (2) | MX363228B (hr) |
MY (3) | MY172063A (hr) |
NO (1) | NO337669B1 (hr) |
NZ (3) | NZ602862A (hr) |
PE (1) | PE20050880A1 (hr) |
PL (5) | PL2319846T3 (hr) |
PT (5) | PT2305683E (hr) |
RS (5) | RS54941B1 (hr) |
SG (3) | SG170736A1 (hr) |
SI (5) | SI2305683T1 (hr) |
TW (3) | TW201509943A (hr) |
WO (1) | WO2005097801A1 (hr) |
ZA (1) | ZA200607181B (hr) |
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